MAUDE Adverse Event Report: COVIDIEN PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	PRB35-07-060-120
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Physician intended to use a protégé everflex device for treatment of a slightly calcified, non-tortuous plaque lesion in the mid superficial femoral artery.The device was prepped as per ifu without issue.The device did not pass through a previously deployed stent.No resistance was encountered when advancing the device and no excessive force was used.During delivery through the vessel a break/fracture occurred at the tip of the device.The stent was deployed and left as is in the patient.The physician claims the stent fractured.The stent was left as is in the patient.No further clinical sequelae reported for this event.
Additional Manufacturer Narrative
Analysis of cine image: the everflex self expanding peripheral stent system was not received for evaluation.A single cine image was received.The cine image is of an implanted stent with a guidewire running through the stent.The image is of just one end of the stent.Due to the quality, clarity, and content of the cine image it is not possible to determine if the image is of the proximal or distal end of the stent.Due to the quality and clarity of the cine image it is not possible to identify individual stent strut rows.The image includes at least three areas of stent offset/pseudo-fracture.The cine image documents an everflex stent deployed within an irregular, calcific lesion.The struts were not evenly spaced within the calcific lesion¿s luminal restrictions (where the stent did not fully expand).It could not be determined whether the strut spacing reflected irregular luminal restriction or if the stent had been deployed while the back (proximal) deployment paddle was being moved forward (distally).There were several gaps in the stent profile documented in the image.Gaps of this nature have been observed when the pseudo-struts separate as a normal result of stent deployment.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 6713278
• Report Number: 2183870-2017-00289
• Device Sequence Number: 10795431
• Product Code: NIP
• UDI-Device Identifier: 00821684069356
• UDI-Public: 00821684069356
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P110023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/06/2020
• Device Model Number: PRB35-07-060-120
• Device Catalogue Number: PRB35-07-060-120
• Device Lot Number: A396902
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2017
• Supplement Date Received by Manufacturer: 07/14/2017
• Initial Report FDA Received Date: 07/14/2017
• Supplement Report FDA Received Date: 08/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 79